Evaluation of strategies aiming at controlling perioperative ischemia - 3 (POISE-3)

Phase 1

• Conditions: The occurrence of life-threatening, major, and critical organ bleeding in patients who are undergoing noncardiac surgery.; MedDRA version: 23.1Level: LLTClassification code 10051014Term: Post procedural bleedingSystem Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-000539-29-IT
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

o Undergoing noncardiac surgery;
o >= 45 years of age;
o Expected to require at least an overnight hospital admission after surgery
o Provide written informed consent to participate in the POISE-3 Trial, AND
o Fulfill >=1 of the following:
• NT-proBNP >= 200 ng/L
• History of coronary artery disease
• History of peripheral arterial disease
• History of stroke
• Undergoing major vascular surgery
• Any 3 of 9 risk criteria
o Undergoing major surgery
o History of congestive heart failure
o History of a transient ischemic attack
o Diabetes and currently taking an oral hypoglycemic agent or insulin
o Age >= 70 years
o History of hypertension
o Serum creatinine > 175 µmol/L (> 2.0 mg/dl)
o History of smoking within 2 years of surgery
o Undergoing emergent/urgent surgery.
Patients will be eligible for inclusion in the cogPOISE-3 substudy if they are enrolled in both the TXA and blood pressure management arms of the POISE-3 trial. cogPOISE-3 patients will be included in the cognitive assessment part of the substudy if they consent to the assessment of their cognitive performance at baseline (i.e., within 30 days prior to randomization) and at 1 year after randomization. Patients with a documented history of dementia will not be eligible for the cognitive
assessment part of the substudy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 750
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 750

Exclusion Criteria

o Patients undergoing cardiac surgery
o Patients undergoing cranial neurosurgery
o Planned use of systemic TXA during surgery
o Hypersensitivity or known allergy to TXA
o Creatinine clearance <30 mL/min (Cockcroft-Gault equation) or on chronic dialysis
o Patients undergoing surgery for pheochromocytoma or history of untreated pheochromocytoma,
o History of seizure disorder
o Patients with recent stroke, myocardial infarction, acute arterial thrombosis or venous
thromboembolism (<3 month)
o Patients with fibrinolytic conditions following consumption coagulopathy
o Patients with subarachnoid hemorrhage within the past 30 days
10. Women of childbearing potential who are not taking effective contraception, pregnant or breast-
feeding
o Previously enrolled in POISE-3 Trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified